Kornimate/medical-research-clean huggingface dataset:
study assessing safety and efficacy of pg324 ophthalmic solution in patients with elevated intraocular pressure

Conditions: Open Angle Glaucoma; Ocular Hypertension

Summary: to evaluate the ocular hypotensive efficacy of pg324 ophthalmic solution relative to its individual components in patients with open angle glaucoma or ocular hypertension.


Eligibility criteria:
inclusion criteria: * 18 years of age or greater. * diagnosis of open angle glaucoma (oag) or ocular hypertension (oht) * corrected visual acuity in each eye equivalent to 20/200 or better * able and willing to give signed informed consent and follow study instructions. exclusion criteria: ophthalmic: * glaucoma: pseudoexfoliation or pigment dispersion component, history of angle closure, or narrow angles. * intraocular pressure \>36 mmhg * known hypersensitivity to any component of the formulation, latanoprost, or to topical anesthetics. * previous glaucoma intraocular surgery or glaucoma laser procedures in study eye(s) * refractive surgery in study eye(s) * ocular trauma within the six months prior to screening, or ocular surgery or laser treatment within the three months prior to screening. * evidence of ocular infection and inflammation * clinically significant ocular disease, which might interfere with the study, including glaucomatous damage so severe that washout of ocular hypotensive medications for one month is not judged safe * central corneal thickness greater then 600 μm * any abnormality preventing reliable applanation tonometry of either eye systemic: * clinically significant abnormalities (as determined by the investigator) in laboratory tests at screening. * clinically significant systemic disease * participation in any investigational study within 30 days prior to screening * changes in systemic medication * women of childbearing potential who are pregnant, nursing, planning a pregnancy, or not using a medically acceptable form of birth control.

Keywords: open angle glaucoma ocular hypertension intraocular pressure ar13324 pg324
gped regimen for relapsed/refractory or advanced enktcl

Conditions: Extranodal NK/T-cell Lymphoma, Nasal Type

Summary: the purpose of this study is to evaluate the efficacy and safety of gemcitabine, pegaspargase, etoposide, and dexamethasone (gped) in the treatment of relapsed/refractory or advanced nk/t-cell lymphoma patients (enktcl).

pegaspargase is the cornor stone for the treatment of enktcl, and gemcitabine has been shown to be active in enktcl. for several patients with relapsed/refractory or advance enktcl, hemophagocytic sysdrome (hps) occurs, and the prognosis is very poor. studies have found that etoposide and dexamethasone may be effective in controlling hps. thus, this study aims to evaluate the role of gemcitabine, pegaspargase, etoposide, and dexamethasone (gped) in the treatment of relapsed/refractory or advance enktcl, wishing to improve the prognosis for these patients.

Eligibility criteria:
inclusion criteria: * histopathology and immunohistochemistry confirmed diagnosis of nk/tcell lymphoma according to who 2016 criteria. * refractory or relapsed after initial remission, or stage iii-iv de novo patients * pet/ct or ct/mri with at least one objectively evaluable lesion. * general status ecog score 0-3 points. * the laboratory test within 1 week before enrollment meets the following conditions: * blood routine: hb\>80g/l, plt\>50×10e9/l. * liver function: alt, ast, tbil ≤2 times the upper limit of normal. * renal function: cr is normal. * cardiac function: lvef≥50%, ecg does not suggest any acute myocardial infarction, arrhythmia or atrioventricular conduction above i blocking. * sign the informed consent form exclusion criteria: * active infection requires icu treatment. concomitant hiv infection or active infection with hbv, hcv. patients who are infected with hbv but not active hepatitis at the same time are notexcluded. * significant organ dysfunction pregnant and lactating women. * those who were known to be allergic to drugs in the study regimen. * patients with other tumors who require surgery or chemotherapy within 6 months. * other experimental drugs are being used.

Keywords: extranodal nk/t-cell lymphoma gemcitabine etoposide dexamethasone pegaspargase hemophagocytic syndrome
established status epilepticus treatment trial

Conditions: Benzodiazepine Refractory Status Epilepticus

Summary: the primary objective is to determine the most effective and/or the least effective treatment of benzodiazepine-refractory status epilepticus (se) among patients older than 2 years. there are three active treatment arms being compared: fosphenytoin (fos),levetiracetam (lev), and valproic acid (vpa). the second objective is comparison of three drugs with respect to secondary outcomes. the final objective is to ensure that the trial is informative for treatment of established se in children by describing the effectiveness, safety, and rate of adverse reactions of these drugs in children.


Eligibility criteria:
inclusion criteria: patient witnessed to seize for greater than 5 minute duration prior to treatment with study drug; patient received adequate dose of benzodiazepines. the last dose of a benzo was administered in the 5-30 minutes prior to study drug administration. the doses may be divided.; continued or recurring seizure in the emergency department; age 2 years or older exclusion criteria:known pregnancy; prisoner; opt-out identification; treatment with a second line anticonvulsant (fos, pht, vpa, lev, phenobarbital or other agents defined in the mop) for this episode of se; treatment with sedatives with anticonvulsant properties other than benzodiazepines (propofol, etomidate, ketamine or other agents defined in the mop); endotracheal intubation; acute traumatic brain injury; known metabolic disorder; known liver disease; known severe renal impairment; known allergy or other known contraindication to fos, pht, lev, or vpa; hypoglycemia \ 400 mg/dl; cardiac arrest and post-anoxic seizures

Keywords: status epilepticus, refractory, benzodiazepine, fosphenytoin, levetiracetam, valproic acid
a trial of postoperative whole brain radiation therapy vs. salvage stereotactic radiosurgery therapy for metastasis

Conditions: Brain Neoplasms; Neoplasm Metastasis

Summary: the aim of this study is to evaluate non-inferiority of salvage stereotactic radiosurgery (srs) in the patients who received surgical resection for brain metastases in comparison with postoperative whole brain radiation therapy (wbrt).

a randomized phase iii study is started in japan to compare postoperative whole brain radiation therapy with salvage stereotactic radiosurgery in patient with one to four brain metastases from lung, breast, and colorectal cancer. total of 270 patients will be accrued for this study from 21 institutions within three years. the primary endpoint is overall survival. the secondary endpoints are proportion of performance status (ps) preservation, proportion of mini-mental status examination (mmse) preservation, and adverse events.

Eligibility criteria:
inclusion criteria: 1. one to four brain metastases with a maximum diameter of 3 cm or more for the largest lesion and additional lesions not exceeding 3 cm in diameter 2. all brain metastases localized within cerebrum or cerebellum 3. before surgical resection for brain metastasis, ps is 0-2, or 3 by cerebral nerve compression neurological deficits 4. surgical resection for the largest brain metastases has achieved 5. after surgical resection, four or fewer (0-4) residual lesions with maximum diameter under 3 cm 6. histologically proven non-small cell carcinoma, breast cancer or colorectal cancer 7. primary lesion and the other metastases (i.e. lung, liver, bone metastases except for brain) is consider to be controlled 8. an age of 20-79 years 9. no prior surgery or irradiation for brain 10. adequate organ function 11. written informed consent(if signing in consent form is difficult for the patient due to paralysis, signing by the family in place of the patient is permitted) exclusion criteria: 1. synchronous or metachronous (within 5 years) malignancy other than carcinoma in situ or mucosal cancer 2. pregnant or breast-feeding women 3. severe mental disease 4. allergic to gadolinium contained contrast agents

Keywords: randomized controlled trials brain neoplasms/secondary brain neoplasms/radiotherapy radiosurgery
icon-2: fmt and bezlotoxumab compared to fmt and placebo for patients with ibd and cdi

Conditions: Inflammatory Bowel Diseases; Clostridium Difficile Infection

Summary: this is a randomized controlled trial to assess the clinical and microbiological impacts of fmt in combination with bezlotoxumab (bezlo) compared to fmt in combination with placebo in patients with both inflammatory bowel disease (ibd) a and clostridium difficile infection (cdi). the investigators will prospectively enroll up to 150 ibd-cdi patients from 4 tertiary care fmt referral centers. patients will be randomized 1:1 to either receive fmt in combination with bezlo of fmt and a placebo infusion. donor stool from healthy donors will be obtained from openbiome. openbiome is a nonprofit 501(c)(3) organization that provides hospitals with screened, filtered, and frozen material ready for clinical use. patients will be enrolled and followed prospectively for 3 months post therapy. stool and blood samples as well as clinical data will be collected at baseline, week 1, 8 and 12.


Eligibility criteria:
inclusion criteria: * adults age 18 or greater * history of ≥ 2 episodes of recurrent cdi. cdi is defined as the presence of diarrhea ( bristol 6 or 7 for 48 hours and a confirmatory test for cdi). preferred testing will be a two-step method using gdh/eia toxin, though pcr will be accepted based on hospital availability with confirmation of the most recent episode occurring within the prior 3 months * confirmed diagnosis of ibd (ulcerative colitis, crohn's disease or indeterminate colitis) * undergoing fmt via colonoscopy for cdi as part of standard medical care exclusion criteria: * unable or unwilling to undergo a colonoscopy * inpatient status, though patients can be screened while inpatients, the must be outpatient for the planned colonoscopy. * anticipated immediate or upcoming surgery within 30 days * need for continued non-anti-cdi antibiotic therapy * history of total proctocolectomy * female patients who are pregnant or breastfeeding or plan to become pregnant in the next 6 months. * patients who are unable to give informed consent * participation in a clinical trial in the preceding 30 days or simultaneously during this trial * severe food allergy (anaphylaxis or anaphylactoid-like reaction) * life expectancy \< 6 months * unable to adhere to protocol requirements * patient who have received an fmt in the past year * any condition that the physician investigators deems unsafe, including other conditions or medications that the investigator determines that it will put the subject at greater risk from fmt * patient who is diagnosed with nyha class 3 or 4 heart failure * lab value of wbc \ 1.5 x institutional uln * ebv or cmv negative if a patient is severely immunosuppressed ( defined as 3 or more immunosuppressing agents)

Keywords: crohn's disease ulcerative colitis
clinical trial of motilitone on gastric motor function in healthy volunteers

Conditions: Healthy Female and Male

Summary: the purpose of this study is to compare the effects of motilitone and placebo on gastric volumes, gastric emptying, small bowel transit and colon transit in female and male healthy volunteers.


Eligibility criteria:
inclusion criteria: * no gastrointestinal symptoms * no organic lesion such as gastrointestinal malignancies, erosive esophagitis, reflux esophagitis, erosive gastroduodenitis, gastric or duodenal ulceration after having normal upper abdominal endoscopy * written informed consent exclusion criteria: * pregnant, breast-feeding female,those of childbearing age who were not using an approved method of contraception * history of abdominal surgery that may influence gastrointestinal motility * gastrointestinal hemorrhage, mechanical ileus, enterobrosis * irritable bowel syndrome, inflammatory bowel disease * severe disturbance of liver, kidney, heart,lung,blood and endocrine * psychoneurosis, alcoholism, drug dependence * medications that may alter evaluation of motilitone including antibiotics,corticosteroids, nsaid within 1 month, prokinetics, h2 blocker, ppi, anticolines, erythromycin, antidepressive agents withing 2weeks
the use of fractionated exhaled nitric oxide in the diagnosis and assessment of disease activity of eosinophilic esophagitis (pilot)

Conditions: Eosinophilic Esophagitis

Summary: the purpose of the study is to evaluate of the relationships between fractionated exhaled nitric oxide, disease activity, and symptom severity in patients with eosinophilic esophagitis compared to those without eosinophilic esophagitis.


Eligibility criteria:
inclusion criteria: * pediatric patient who will undergo esophagogastroduodenoscopy with biopsies at children's memorial hermann hospital, as part of the standard of care in the evaluation of eoe * able to perform the single-breath exhalation for the hand-held analyzer, niox mino (aerocrine, sweden) * signed informed consent by a parent or legal guardian * signed assent form by the child/adolescent subjects 7-18 years of age exclusion criteria: * past medical history of asthma, allergic rhinitis, ibd, parasitic infection, hay fever and any exposure to smoking (including secondhand smoke) because these disorders are known to affect the feno levels * active respiratory tract infections at the time of feno evaluation because this can affect the result of the feno as well * asthma questionnaire and/or spirometry test consistent with asthma
fdg-pet in the diagnosis of autoimmune encephalitis

Conditions: Autoimmune Encephalitis

Summary: the goal of this retrospective observational study is to compare brain fluorodeoxyglucose-positron emission tomography (fdg-pet) of patients with autoimmune encephalitis, normal controls and patients with alzheimer's disease (ad). the main question it aims to answer is: •is there a specific pattern of brain metabolism in patients with autoimmune encephalitis participants data and images will be retrospectively collected from hospital records, and fdg-pet images will be analyzed by means of statistical parametric mapping (spm). controls will be selected from validated public databases.


Eligibility criteria:
inclusion criteria: * diagnosis of autoimmune encephalitis according to clinical criteria * brain magnetic resonance imaging performed between clinical presentation and treatment * cerebrospinal fluid analysis performed between clinical presentation and treatment * brain fdg-pet performed between clinical presentation and treatment * autoantibodies testing performed between clinical presentation and treatment exclusion criteria: * refusal to give consent for the study

Keywords: autoimmune encephalitis fdg-pet spm
safety and treatment effect of qbeco in moderate to severe crohn's disease

Conditions: Crohn's Disease; Inflammatory Bowel Disease

Summary: the purpose of this study is to evaluate the safety profile and to obtain an indication as to the therapeutic effect of qbeco induction treatment on clinical improvement in moderate to severe crohn's disease.


Eligibility criteria:
inclusion criteria: * an adult, age 18 and above * diagnosed with crohn's disease at least six (6) months prior to screening * crohn's disease diagnosis was verified by one of these procedures: 1) colonoscopy 2) capsule endoscopy 3) computed tomography (ct) scan 4) magnetic resonance imaging (mri) 5) ultrasound * active crohn's disease at the time of screening * female participants: agree to practice two effective methods of contraception, at the same time, from the time of signing the informed consent form, during the entire study treatment and for two (2) months after taking the last dose of study treatment. * male participants: agree to practice effective barrier contraception during the entire study treatment period and for two (2) months after taking the last dose of study treatment. exclusion criteria: * currently pregnant or breastfeeding * have known or suspected hypersensitivity to any component of the product * had more than three (3) small bowel resections or diagnosis of short bowel syndrome * currently anticipate undergoing any major surgical intervention for crohn's disease during the next six (6) months * previously been treated with any qu biologics' site specific immunomodulators (ssis) for any disease * diagnosed with chronic (i.e., long term) hepatitis b or c infection * diagnosed with congenital (i.e., existing at or before birth) or acquired immunodeficiency (i.e., lack of body defense system). for example, human immunodeficiency virus (hiv) infection, organ transplantation (i.e., specifically received an organ from a donor), etc. * daily use of narcotic drugs containing opiates (such as morphine, codeine, etc.) for pain control * have a current or recent history (within the past 12 months) of alcohol dependence or illicit drug use, with the exception of medicinal marijuana prescribed by a physician * have a history of cancer within the last five (5) years. exceptions may apply for cervical cancer and some forms of skin cancer

Keywords: crohn's disease inflammatory bowel disease cdai
survivin peptide vaccination for patients with advanced melanoma, pancreatic, colon and cervical cancer

Conditions: Malignant Melanoma; Pancreatic Cancer; Colon Cancer; Cervical Cancer

Summary: this study evaluates the safety, the immunological response and the clinical outcome of a vaccination with survivin peptides for patients with advanced melanoma, pancreatic, colon and cervical carcinoma.

as prognosis of advanced melanoma, pancreatic, colon and cervical cancer remains gloomy, new therapeutic modalities have to be developed to improve the patient´s clinical outcome. immunotherapy, which targets tumor associated antigens of tumor cells or tumor stroma, is currently an intensively investigated, novel therapeutic option. as survivin is expressed both by neoplastic cells as well as by endothelial cells of the tumor vasculature, this antigen is an intriguing target molecule. spontaneous cytotoxic t-cell responses against different survivin epitopes in cancer patients underline the relevance of survivin-directed immunological trials. this study is comprised of a peptide vaccine with hla-a1, -a2 and -b35 restricted survivin epitopes in montanide isa-51 for patients with stage iv melanoma, advanced pancreatic, colon and cervical carcinoma. the vaccine is applicated as a deep subcutaneous injection. vaccination is administered for the first 2 months weekly, afterwards every 4 weeks. standard staging examinations are performed every three months. clinical, laboratory and immunological monitoring is done every month.diagnostic leucapheresis is performed before first vaccination and afterwards every 2 months.

Eligibility criteria:
inclusion criteria: * advanced melanoma, pancreatic, colon and cervical cancer * at least 1 prior postoperative conventional therapy (chemotherapy, radiation, immunotherapy) * hla-a1, -a2, -b35 * more than 4 weeks since last chemo-, immune- or radiotherapy * ecog-ps (eastern cooperative oncology group- performance status) of 0-1 * sufficient renal, hepatic and bone marrow function: thrombocytes \> 75.000/ul; hb \> 9 g/dl; leucocytes \> 2.500/ul; creatinine \< 2 mg/dl; got/gpt \< twice the normal value * negative for hiv and hbs * older than 18 years * informed consent exclusion criteria: * acute/chronic infections * positive for hiv, hbs * autoimmune disorders * pregnancy, breast feeding

Keywords: peptide vaccine therapy survivin
non-pharmacological treatment of psychosis

Conditions: Psychosis; Schizophrenia-Like

Summary: the objectives of the project are to investigate feasibility, safety, and health-related outcomes in patients with psychosis who choose not to use antipsychotic drugs (aps). the instruction from the ministry of health and care services to establish "medication free" (non-pharmacological (nonpharm)) treatment services, which has received substantial critique for being given without support in scientific evidence, provides a window of opportunity for research in an under-investigated field. the study will prospectively follow a cohort over 1 year who seeks nonpharm treatment, with repeated measurements of symptoms, functional outcomes, quality of life, adverse events, as well as biological parameters including genetics and brain imaging, and environmental factors, and compare the findings to a control group of users of antipsychotic drugs, matched for age, gender and diagnosis. current unanswered questions in the treatment of psychosis include which patients can successfully and safely discontinue antipsychotic medication; and what are the long-term symptomatic, biological and functional outcomes after use or non-use of aps, respectively. taken together there is a fundamental lack of high-quality evidence to guide the treatment options in people who cannot or do not want to use aps in psychosis. this is also a major challenge in the study, as a more rigorous design that could directly compare different treatment options is not feasible, because no alternatives to aps have proven to be sufficiently effective and safe in controlled trials. the study is accordingly expected to provide new exploratory information that could be the basis of intervention studies which in its turn could provide important information for consumers and the mental health services regarding treatment options in psychosis.


Eligibility criteria:
inclusion criteria: * fulfillment of diagnostic criteria for schizophrenia or related disorder (corresponding to chapter f2 in the icd-10) * the clinician responsible for the treatment must consider nonpharmacological treatment to be professionally justifiable in the patient in question * patient being able/ capable of providing informed consent * patient receiving active treatment including different psychosocial treatments * patient having a treatment plan and a crisis resolution plan. exclusion criteria not fullfilling inclusion criteria
smartscope vs standard colposcope for the evaluation of cervical dysplasia

Conditions: Cervical Cancer

Summary: this trial will compare images obtained from a mobile colposcope with those obtained using a standard of care.

this trial will compare images obtained from a mobile colposcope with those obtained using a standard colposcope in women with abnormal pap smears. it is a non-inferiority trial. blinded images will be evaluated be experts in colpsocopy and compared

Eligibility criteria:
inclusion criteria: abnormal cervical cancer screening by pap smear of high risk hpv test - exclusion criteria: no consent -

Keywords: screeening
lung fibrotic changes associated with sars-cov-2 infection

Conditions: Pulmonary Fibrosis

Summary: prospective, observational, multicenter study that will evaluate the changes in lung function that patients admitted with sars-cov-2 pneumonia will present according to the level of severity at 4, 12, 26 and 52 weeks after hospital discharge.

the project consists of a prospective, observational, multicenter study that will evaluate changes in lung function (forced spirometry, measurement of static lung volumes using plethysmography and pulmonary carbon monoxide diffusion test) that patients admitted with pneumonia will present. caused by sars-cov-2 according to the level of severity at 4, 12, 26 and 52 weeks after discharge from hospital. restrictive pulmonary abnormalities will be confirmed by imaging tests (high resolution chest ct).

Eligibility criteria:
inclusion criteria: * patients admitted for bilateral pneumonia caused by sars-cov-2 (confirmed by pcr). * age over 18 years. * acceptance of informed consent. * life expectancy over 1 year. exclusion criteria: * patients with a previous diagnosis of interstitial lung disease. * inability to attend review visits.